Blood glucose monitoring test systems for prescription point-of-care use: guidance for industry and Food and Drug Administration staff

Blood glucose monitoring test systems for prescription point-of-care use: guidance for industry and Food and Drug Administration staff

Collection:
Health Policy and Services Research
Series Title(s):
Guidance for industry
Contributor(s):
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Devices and Radiological Health (U.S.), issuing body.
Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, September 29, 2020
Language(s):
English
Format:
Text
Subject(s):
Blood Glucose
Equipment Safety
Point-of-Care Testing
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
Genre(s):
Technical Report
Abstract:
This guidance document describes studies and information that FDA recommends be used when submitting premarket notifications (510(k)s) for blood glucose monitoring systems (BGMSs) which are for prescription point-of-care use. This guidance document is intended to guide manufacturers in conducting appropriate performance studies and preparing 510(k) submissions for these device types, and replaces the final guidance entitled “Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use” issued on October 11, 2016. This guidance is not meant to address self-monitoring blood glucose test systems (SMBGs) for over-the-counter (OTC) home use by lay-users. FDA addresses those device types in another guidance entitled “Self-Monitoring Blood Glucose Test Systems for Over-theCounter Use” (SMBG guidance). FDA is also issuing a revised SMBG guidance to reflect similar clarifications to the ones discussed in this guidance.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (42 pages)).
NLM Unique ID:
9918232103106676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918232103106676